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"ADAPT" The Adaptation to High Fat Diets Extention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00493701
First received: June 26, 2007
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

This study is designed to predict weight gain overtime after a high fat diet.


Condition Intervention
Healthy
Behavioral: High Fat Diet
Behavioral: Low Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: ADAPT-The Adaptation to High Fat Diets

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype. [ Time Frame: 4 days of high fat diet ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue. [ Time Frame: 4 days after high fat diet ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: October 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle
Measurement of body weight in a fown with light undercloting (30 minutes) and height.
Behavioral: High Fat Diet
Daily eating
Other Name: Measurements will be collected to help with gathering data.
DEXA Scanner
Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
Behavioral: Low Fat Diet
Life style eating habits
Other Name: Questionnairs of food frequency

Detailed Description:

In the past 3 years we have identified a "thrifty-phenotype" characterized in lean men by an inability to adapt rapidly to a high fat diet and associated with a low maximal VO2 and high fasting insulin. We hypothesize that the individuals with the "thrifty phenotype" are at higher risk for becoming obese, and that exercise may be effective in overcoming this problem.

Several questions remain to be answered regarding the "thrifty" phenotype. First, given the large interindividual differences, how can we identify those at the highest risk? What are the distinguishing biochemical, endocrine and environmental characteristics of individuals that store fat when exposed to high fat diets? This is important because if these individuals can be easily identified, then dietary interventions can be targeted to this "at-risk" population.

Second, what is different about the individual with the "thrifty phenotype"? Are there cellular pathways that are dysregulated in the skeletal muscle of these individuals when compared to controls? Is the defect intrinsic, i.e. a diminished ability to conserve glucose and oxidize fat in skeletal muscle or alternately, is the phenotype due to environmental, and dietary factors such as inactivity and energy excess?

To answer these questions, we have planned a three-year project that aims to:

  • Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
  • Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.
  • Determine the role of environmental factors such as inactivity and caloric intake vs. intrinsic (genetic) factors in the "thrifty" phenotype.
  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both genders and all races will be invited to participate
  • Women will be asked to participate in the follicular phase of the menstrual cycle as determined by menstrual history and a negative pregnancy test will be recorded prior to participation
  • BMI > 19 and < 35
  • Age 18-30 Exclusion Criteria
  • Smokers
  • Unwilling or unable to abstain from alcohol consumption and caffeine consumption prior to testing and laboratory
  • Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease
  • Pregnancy
  • Corticosteroid use in previous two months
  • Chronic use of anti-diabetic, anti-hypertensive, or other medications known to affect fat metabolism
  • Use of Depo-Provera, hormone implants or estrogen replacement therapy
  • Irregular menstrual cycles
  • Post-menopausal women
  • Weight gain or loss of > 3kg in the last 6 months

For the MRI, the following exclusion criteria apply:

  • Individuals who have a heart pacemaker, defibrillator, or non-removable hearing aid
  • Individuals with any clips or metal plates in their head
  • Individuals who have any artificial limbs or prosthetic devices
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals, who wear braces on their teeth, have non-removable false teeth, or removable bridgework
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493701

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George A. Bray, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00493701     History of Changes
Other Study ID Numbers: PBRC21041
Study First Received: June 26, 2007
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014